(64 days)
The Spectrum Spine Cervical Cage System devices including those with macro-, micro- and nano-roughened surface textured features are indicated for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. These patients should have had at least six weeks of nonoperative treatment. The Spectrum Spine Cervical Cage System is indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.
The Spectrum Spine Cervical Cage System is composed of cervical interbody fusion devices. The Spectrum Spine Cervical Cage System is offered in five footprints with varying heights and lordotic angles designed to accommodate patient anatomy. Additionally, all interbody cages are offered with a smooth finish and a rough finish. The interbody devices also contain a large graft window through the body of the device to allow for placement of bone graft and facilitate fusion. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
The Spectrum Spine Cervical Cage System also includes instruments to facilitate implantation of the subject implant devices. Instruments are manufactured from medical grade stainless steel.
The provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria, specifically concerning a digital health device or AI/ML product.
The document is a 510(k) clearance letter from the FDA for a Spectrum Spine Cervical Cage System, which is a physical implant used for spinal fusion. The information provided relates to the physical and mechanical properties of this implant, not a software or AI device.
Therefore, I cannot provide the requested information, as these details are not present in the given text.
To address your request, here's what the provided text does include, which is relevant to the Spectrum Spine Cervical Cage System (a physical medical device):
- Device Name: Spectrum Spine Cervical Cage System
- Intended Use: Anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, confirmed by imaging studies, resulting in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. Patients should have had at least six weeks of nonoperative treatment. To be used with supplemental fixation and specific bone graft materials.
- Performance Testing (Mechanical): Static and dynamic axial compression, static and dynamic compression shear, static and dynamic torsion per ASTM F2077-22, as well as subsidence per ASTM F2267-22 and expulsion. The results of these tests showed the device to be substantially equivalent to predicate interbody devices.
None of the requested points (acceptance criteria for digital device, sample size for test set, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, ground truth type, training set size, training set ground truth establishment) are applicable or present in this document.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.